Many hospital patients and nursing home residents suffer from an inability to restrain natural urinary discharge. This condition, referred to as incontinence, is evidenced by the involuntary intermittent or continuous flow of urine from the bladder as a result of an ineffective sphincter muscle or muscles which normally closes the urethra. The sphincter muscles may be weak, as is often the case with older individuals, particularly bed patients, or they may have been torn or otherwise damaged. A common cause of sphincter muscle damage in women occurs during childbirth. The disorder also occurs after prostate gland surgery in men. The condition is sometimes referred to as "stress incontinence" because of the minimal stress, if any, required to void the bladder.
Patients or residents who suffer from incontinence are generally furnished with an indwelling urinary catheter equipped with a flexible catheter drainage tube which is connected to a urinary discharge or drainage bag which collects the urine as it is passed by the patient or resident. The indwelling catheter is inserted directly into the urethra or the bladder and must be maintained in this position for many of these incontinent patients or residents for days at a time. A preferred catheter, referred to as a "Foley" catheter, is inserted directly into the bladder through the urethra. Once the tip of the "Foley" catheter is in the bladder, water or air is used to inflate the tip of the catheter so that the inflated tip does not slip back out of the bladder through the urethra which is much smaller than the now inflated catheter tip.
Unfortunately, the indwelling urinary catheter, especially "Foley" catheters, can cause bacterial infection in the patient's or the resident's urethra or bladder when the catheter drainage tube is allowed to become contaminated with bacteria. Serious infection may result if it is not recognized and treated promptly, thereby resulting in cases of septic shock where the infection goes untreated for a period of time. This condition is life threatening, especially for older individuals who have a reduced capacity to fight off such infections. The Applicants have observed that 85-90% of the patients/residents they have observed with septic shock in hospitals and nursing homes, developed this condition as a result of a bladder infection. In addition, about 85-90% of those patients/residents had an indwelling "Foley" catheter inserted into the bladder and connected to a gravity flow drainage system. It is believed that such an infection is often a result of a failure of the gravity flow drainage system to drain properly, thereby allowing urine to collect in vertical loops or low areas in the drainage tube. The stagnant urine provides a medium for exponential growth of infectious bacteria. When additional urine is passed by the patient/resident and stagnant urine has collected and bacteria have multiplied in low points in the drainage tube, the newly passed urine can mix with the stagnant urine and back up into the urethra and/or the bladder, thereby causing infection which can result in acute septic shock. Furthermore, when stagnant urine collects in low points in the drainage tube which are closer to the catheter than the to the drainage bag, there is a greater chance that bacteria could "creep" or grow along the inside wall of the tube, reaching the catheter and infecting the bladder and/or urethra, when the distance to traverse is less than it would otherwise be. Some manufacturers have inserted check valves in the urine tube in an attempt to prevent backflow of urine but infections continue to occur.
This problem can occur because the flexible urinary catheter drainage tube attached to the indwelling catheter generally has a length which is adapted to provide a gravity flow drainage system for a patient or resident who is lying in a bed. When the patient is moved from a bed to a wheelchair, however, the drainage tubing is generally much longer than is needed to reach a drainage bag which is somehow attached to the wheelchair. Therefore, when the patient/resident is sitting in a wheelchair, the drainage tube has extra length which is not required. This excess drainage tubing is generally collected in such a way that the excess catheter tubing is allowed to loop in a manner which runs perpendicular to the floor. These vertical loops have low spots which are potential areas for collecting stagnant urine and for interrupting the gravity flow drainage system.
The drainage system generally used for indwelling catheters is based on the natural flow of the urine drawn by the force of gravity after it leaves the bladder through the indwelling catheter. If uninterrupted, the urine will flow from the catheter to the drainage bag via the catheter drainage tube. Once this system is interrupted, however, the chance for infection of the bladder is increased. The vertical loop or loops in the excess catheter tubing, often created when a patient/resident is moved from a bed into a wheelchair, allow for interruption of the gravity flow drainage system, because urine collects in low spots in these loops. This problem is especially significant for those patients or residents with low urinary outputs. In such cases, often resulting from renal failure or poor fluid intake, the urine collects and becomes stagnant in low spots in the vertical loops. This is because the quantity of urine passed by the individual patient or resident is not sufficient to push the urine through the low spots and past the adjacent elevated spots in the loops due to the force of gravity. When the urine collects in this way it interrupts the gravity flow drainage system and allows for a high possibility of exponential bacterial multiplication in the drainage tube at a point which is much closer to the bladder than the more removed drainage bag. Also, because of the gravity-induced interruption in the gravity flow drainage system caused by the effect of the vertical loop, which requires the urine to pass through a high point in the loop before it will leave the loop containing the low point, the urine may back up into the catheter after failing to pass through such a high point, thereby allowing for a further potential for contamination and infection.
Another serious problem is contamination of the external surface of the bag and tubing by contact with the floor or other unsanitary surfaces since bacteria may then travel along the external surface of the bag and tube and enter the bladder via the external surface of the catheter.
Other problems exist as well. Wheelchairs have no appropriate place to hang the drainage bag itself. If the bag is hung over or under the side arm board of the wheelchair, the drainage bag is placed at a level only inches above or below the level of the bladder which makes it very difficult to maintain a gravity flow drainage system. Another option for hanging the drainage bag is the junction between the crossbraces located below the seat of the wheelchair. Unfortunately this puts the drainage bag in close proximity with the floor, increasing the chance of cross-contamination and damage to the bag when the wheelchair is moved. Furthermore, the bag draws visual attention when it hangs so low below the wheelchair especially if it drags along the floor when the wheelchair is moved. This visual attention diminishes the privacy which patients/residents would otherwise have, and can be an embarrassment to them. Furthermore, attempts to hook the drainage bag to the cross-braces, which are generally about 1 inch in diameter, result in frequent disconnections resulting in the drainage bag ending up on the floor and being exposed to contamination because proper attachment means have not been made available with many of the drainage bags previously available. Some institutions have developed solutions including the use of home-made container devices, such as cloth purses, which are designed to contain the drainage bag. However, when the drainage bag sits in such a device, which may be hung below the side arm board, the excess catheter tubing still possesses vertical loops which are perpendicular to the floor, thereby causing interruptions in the gravity flow drainage system. The frequency of cleaning such cloth bags is a concern in maintaining sanitary conditions around the catheter tubing and the drainage bag.
One partial solution to this problem would be to switch the drainage tube when the patient/resident is switched from a bed to a wheelchair. However, even if a simple disconnect system could be designed, it would require opening the otherwise "closed" system, increasing the chance of bacterial entry into the closed system from the outside surface of the tubing, thus providing additional potential for contamination which could lead to infection. Furthermore, such a system would not be readily accepted by those who are required to do the extra work of switching tubes every time a patient is moved from the bed to the wheel-chair and vice versa.
It will be appreciated from the foregoing that there are many problems associated with the need for urinary catheterization which are in need of solutions. The present invention provides solutions for these and other problems which have not been discussed.